Gsk
Biopharmaceutical
SeniorManagerorAssociateDirector,AnalyticalDevelopment
“Senior Manager or Associate Director, Analytical Development at Gsk. Skills: Analytical Development, Biologics, Method Development, CMC. Lead and manage analytical development activities. Manage method development”
Industry & Context.
Troubleshooting; Investigations
What They're Looking For.
Must Have
Ph.D. , M.S. or B.S. in chemistry, biochemistry, cell biology, biochemicalioprocess engineering, or related science/engineering field with extensive biopharmaceutical industry experience, 6+ years (for Ph.D.) or 8+ years (for M.S.) or 10+ years (for B.S.) of biopharmaceutical industry experience, 5+ years of hands-on experience with biochemical, biophysical and/or biological methods used for biopharmaceutical characterization, 3+ years of CMC analytical development experience, Experience in technical transfer of methods and life cycle management
Nice to Have
Experience with a variety of biologic modalities, Exposure to all stages of biologics drug development, Hands-on experience in biochemical and/or biophysical assay development, qualification/validation, Thorough knowledge of structure-function relationship of therapeutic proteins, Proven ability to manage projects and work with cross-functional teams, Ability to work in a fast-paced, multi-disciplinary and dynamic environment, Flexibility to support multiple development programs simultaneously, Ability to lead innovation, change, and drive for results
What You'll Do.
Lead and manage analytical development activities
Manage method development
Manage method qualification/validation
Manage method transfer
Manage characterization of drug substance
Manage characterization of drug product
Manage in-process testing
Manage reference standards qualification
Develop strategies for product characterization
Develop strategies for process characterization
Execute strategies for product characterization
Execute strategies for process characterization
Facilitate tech transfer of methods to GMP testing
Facilitate tech transfer to commercial groups
Facilitate tech transfer to CMO's
Collaborate with process functions
Collaborate with quality functions
Ensure cross functional collaborations
Ensure integrated process development
Ensure integrated product development
Author key source documents for regulatory filings
Review key source documents for regulatory filings
Approve key source documents for regulatory filings
Lead analytical development commitments
Track analytical development commitments
Support CMC filing activities
Draft regulatory filings
Review regulatory filings
Assure documentation is maintained
Assure regulatory compliance systems are maintained
Establish processes with CRO/CDMO business partners
Implement processes with CRO/CDMO business partners
Establish technical concepts with CRO/CDMO business partners
Implement technical concepts with CRO/CDMO business partners
Establish methodologies with CRO/CDMO business partners
Implement methodologies with CRO/CDMO business partners
Partner with Quality Assurance
Partner with Regulatory Affairs-CMC
Ensure completion of appropriate documentation
Ensure maintenance of high-quality standards
Provide clear communication to partners
Provide clear communication to functional line management
Communicate progress against technical objectives
Communicate progress against project objectives
How You'll Work.
Team & Collaboration
Cross-functional teams; CRO/CDMO business partners; Quality Assurance; Regulatory Affairs-CMC
Communication Scope
Clear communication
Process & Methodology
Project leadership, Technical project management
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